This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Balance Training for Elders With Heart Failure (NCT02566785), a randomized na study. The primary outcome is Pre/Post Scores on the 30 Second Sit to Stand Test Will be Used to Detect Any Changes in Leg Strength and Endurance That Occur During the 12 Week Group Exercise Sessions..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02566785 |
| Phase | NA |
| Condition | Heart Failure |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | None (open label) |
| Enrollment | 33 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Nebraska |
| Results posted | Yes |
2. Clinical Question
Population
Older, community-dwelling adults with heart failure were the intended population. The registry describes the study as a pilot evaluating a multi-component balance and resistance-training intervention. It does not report more detailed eligibility criteria or the age distribution of enrolled participants.
Intervention
The intervention combined balance activities and strengthening. Participants allocated to the intervention group were assigned a supervised group exercise session one time per week and were asked to exercise two more times per week at home. The registry does not report adherence or how much exercise participants completed.
Comparator
The wait-list control group was asked to continue usual activity during the first 12 weeks and to receive the multi-component balance intervention during weeks 12-24. This delayed-start arrangement allows a comparison during the initial period, but the registry does not provide a numerical comparison of outcomes during that period.
Primary question
The primary outcome was the pre/post score on the 30 Second Sit to Stand Test, intended to detect changes in leg strength and endurance during the 12 week group exercise sessions. Scores are expressed as the number of sit to stand cycles. The record does not report the group means, standard deviations, or an estimated treatment contrast, so it does not establish the size or precision of any difference.
3. Trial Design
The registry describes a randomized, unmasked, crossover study of the BASIC balance and strengthening intervention. Enrollment was 33, and the record lists the study as completed. The study start date was 2016-02-01, and primary completion was 2016-12-16. The listed condition is heart failure, and the sponsor is the University of Nebraska.
The intervention group was assigned supervised group exercise one time per week and was asked to complete two additional home exercise sessions per week. The wait-list control group was asked to continue usual activity during the first 12 weeks, then receive the intervention during weeks 12-24. This is a delayed-start arrangement: the initial period provides the stated usual-activity comparison, while the later period provides an opportunity for the wait-list group to undertake the intervention.
The registry labels the model as crossover, but it does not report the sequence allocation details, a washout period, or an analysis that accounts for period or sequence effects. The presence of delayed intervention does not by itself show how measurements across periods were analyzed. Masking is listed as none, so the record does not describe blinded outcome assessment.
The primary outcome is the 30 Second Sit to Stand Test at baseline and 12 weeks. The record notes that two participants in the wait-list control group were there for testing at 12 weeks. No further participant flow, outcome completion, adherence, or analysis-population details are reported. The intervention is described as a pilot intended to evaluate physical function, balance, falls, perceptions, adherence, and feasibility; the record does not provide numerical findings for those broader aims.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Intervention Group | Wait List Control Group |
|---|---|---|
| STARTED | 15 | 18 |
| COMPLETED | 14 | 15 |
| NOT COMPLETED | 1 | 3 |
Reasons for not completing this period:
| Reason | Intervention Group | Wait List Control Group |
|---|---|---|
| Lost to Follow-up | 0 | 2 |
| Worsening condition | 1 | 1 |
Analysis population for the primary outcome, as defined in the registry: Two of the participants in the WLC group were there for testing at 12 weeks.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Intervention Group | Wait List Control Group | Total |
|---|---|---|---|---|
| Participants analysed | 15 | 18 | 33 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 15 | 18 | 33 |
| Sex: Female, Male: Female | Participants | 8 | 8 | 16 |
| Sex: Female, Male: Male | Participants | 7 | 10 | 17 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 15 | 18 | 33 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 15 | 18 | 33 |
6. Primary Endpoint
The registry lists the primary outcome as Pre/Post Scores on the 30 Second Sit to Stand Test Will be Used to Detect Any Changes in Leg Strength and Endurance That Occur During the 12 Week Group Exercise Sessions., measured over Baseline and 12 weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | number of sit to stand cycles |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the score on the 30 Second Sit to Stand Test, recorded as the number of sit to stand cycles. The registry says pre/post scores are intended to detect changes in leg strength and endurance during the 12 week group exercise sessions. It specifies a mean as the summary measure and a standard deviation as the measure of dispersion, with assessments at baseline and 12 weeks.
In general, a repeated sit-to-stand task gives a functional measure based on completing successive transfers from sitting to standing over a set testing interval. It can serve as an indicator of lower-body functional performance. That general rationale does not establish that the measure captures every aspect of balance, falls, or daily function, and it should not be treated as a direct count of falls.
The registry record does not provide the observed means or standard deviations at either assessment, a change score, or a comparison between groups. It therefore does not permit a reader to assess the observed magnitude, variability, or precision of change on this endpoint. The listed secondary outcome is the Activity Balance Confidence Scale, but numerical results for that measure are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive limitation is that the registry identifies the primary measure and its assessment times but does not report numerical results for it. There are no posted group means, standard deviations, mean changes, between-group estimates, confidence intervals, or p-values for the 30 Second Sit to Stand Test. The record also lists no analyses. Consequently, the magnitude and direction of any outcome difference, and the precision with which it was estimated, are not reported in the registry record.
The registry describes the intended comparison as a randomized study with an initial usual-activity period for the wait-list control group and an exercise intervention for the intervention group. That design description alone is not an outcome finding. It cannot establish whether scores changed in either group, whether changes differed between groups, or whether any difference was attributable to the intervention. No conclusion about efficacy can be drawn from the design description or the study’s stated aims.
The record identifies the trial as a pilot and lists aims beyond the primary functional measure, including balance, falls, perceptions, adherence, and feasibility. These aims help explain the study’s scope, but the record does not report numerical findings for them. The only listed secondary outcome is the Activity Balance Confidence Scale; its results are also not reported in the registry record. The registry does not give a numerical falls outcome or a summary of focus-group findings.
The primary outcome description notes that two participants in the wait-list control group were there for testing at 12 weeks. This is relevant context for interpreting follow-up, but the record does not explain the extent or reasons for outcome noncompletion, whether other participants had measurements, or how missing measurements were handled. The note alone cannot establish the degree of missingness or its effect on any estimate.
Safety information is limited to the registry’s adverse-event counts: no serious adverse events are recorded in either group, while one other adverse event is recorded in the intervention group and none in the wait-list control group. These are counts in a small pilot record, not estimates of comparative risk. The registry does not identify the non-serious event or provide a causal assessment. The absence of a recorded serious event in these groups should not be interpreted as proof that the intervention has no risks.
Overall, the posted record describes a planned comparison and reports limited safety counts, but it does not supply the outcome analysis needed to quantify benefit, harm, or uncertainty. Statistical interpretation of the primary endpoint is therefore restricted to its definition, intended timing, and the absence of reported estimates.
9. Statistical Methods Explained
What does a mean and standard deviation describe?
The registry specifies the mean and standard deviation for the continuous primary outcome. In general, a mean describes the average score in a group. A standard deviation describes how spread out individual scores are around that average. The mean alone does not show how similar or different participants’ scores were, while the standard deviation does not by itself indicate whether a difference between groups is meaningful. Both are descriptive quantities; an inferential comparison is needed to estimate uncertainty about a group contrast.
For a pre/post outcome, a reader would usually want to know the scores at baseline and follow-up, the change within each group, and the difference in change between groups or another prespecified contrast. These quantities address different questions. A change within the intervention group does not, on its own, separate intervention effects from time trends, repeated testing, or other influences. A concurrent comparison can help address some of those issues if it is analyzed appropriately. The registry record does not report these numerical estimates or the analysis used.
What would a confidence interval add?
In general, a confidence interval expresses the statistical uncertainty around an estimated quantity, such as a mean difference. Its width depends on factors including variability and the amount of information available. A narrow interval indicates greater precision than a wide interval, while an interval that includes values on both sides of a null contrast may be compatible with several possible effects. A confidence interval does not guarantee that the estimate is correct, and it does not address biases caused by design or missing data.
No confidence interval for the primary outcome is reported in the registry record. This prevents assessment of precision and means there is no basis for describing which effect sizes are compatible with the posted results. The same applies to p-values: none are reported for the primary endpoint, so statistical significance cannot be assessed from the registry record.
How should the crossover label be understood?
In general, a crossover design exposes participants to more than one condition or period, with measurements that may be correlated within a participant. Analyses may need to account for that correlation and for period, sequence, or carryover effects, depending on the actual design. A delayed-start or wait-list arrangement also has a time structure: groups may differ in what they receive during one period and later receive the intervention in another period.
The registry labels the model as crossover and describes the wait-list group’s transition from usual activity during the first 12 weeks to intervention during weeks 12-24. It does not report a statistical model, sequence details, a washout period, or how repeated observations were handled. Therefore, it is not possible to determine whether the posted analysis—none is listed—accounted for within-participant dependence or period effects.
Why can over-dispersion matter?
In general, over-dispersion occurs when observed variability is greater than a statistical model assumes. It can make standard errors too small if ignored, resulting in confidence intervals that are too narrow and tests that appear more conclusive than warranted. This issue is especially relevant to some count outcomes, but the primary endpoint is described as a continuous mean with a standard deviation. The registry record does not report an analysis model or diagnostics, so there is no basis to say whether over-dispersion was relevant to any analysis in this trial.
What can planning calculations tell a reader?
In general, sample-size calculations are planning tools based on assumptions about the target effect, variability, allocation, and statistical method. They are not results observed in participants. A calculation based on an observed effect can illustrate how a future study might be planned around that effect, but it is not evidence that the effect is stable or unbiased. Small pilot estimates can be imprecise, so using them as planning assumptions requires caution.
The registry’s stated planning illustration assumes a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect defined as a stated fraction of the observed effect. It specifies that non-time-to-event illustrations are expressed as participants per arm. Such planning figures are not observed power and do not substitute for the trial’s outcome analysis. The registry record does not report a statistical analysis plan, a sample-size justification for the trial, or interim analyses. Numerical planning estimates are not reported in the registry record.
What is and is not available for reanalysis?
In general, recalculation from posted summary statistics can check a simple unadjusted comparison, but it cannot reproduce an adjusted analysis without the model details or participant-level data. It also cannot resolve missing-data bias or design issues. Here, the registry does not post the primary outcome means and standard deviations needed for a simple recalculation, and it lists no analyses. No recalculated effect estimate can therefore be derived from the registry record.
The registry’s endpoint description, design information, and adverse-event counts can be summarized, but they do not provide the ingredients for a numerical treatment-effect analysis. Any inferential claim would require results and analysis details that are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists three outcome measures and identifies the 30 Second Sit to Stand Test as the primary outcome. The Activity Balance Confidence Scale is listed as a secondary outcome. The other outcome measures are not identified by name in the available record. It does not report a multiplicity strategy, such as a prespecified hierarchy or adjustment across outcomes. Without such information, the registry record does not show how the risk of false-positive findings across multiple tests was addressed. In this case, no outcome analyses are listed, so there are no reported significance tests to interpret.
Missing-data information is also limited. The primary outcome is scheduled at baseline and 12 weeks, and the record notes that two participants in the wait-list control group were there for testing at 12 weeks. It does not state the number with complete baseline and follow-up measurements in each group, why measurements may be absent, or whether the listed observation represents the full follow-up information. The registry does not report imputation, a complete-case analysis, or another missing-data method.
The record does not define analysis populations, such as whether all randomized participants were to be analyzed as allocated or whether analyses were restricted to participants with observed outcomes. It does not report exclusions after randomization, adherence-based analyses, or how the crossover periods were treated in the analysis. These omissions matter because different analysis choices can change both the estimate and its uncertainty. The primary outcome findings and the handling of missing observations are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Intervention Group | 0 | 15 | 0.0% |
| Wait List Control Group | 0 | 18 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Intervention Group | 0 of 15 |
| Wait List Control Group | 0 of 18 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Intervention Group | 1 of 15 |
| Wait List Control Group | 0 of 18 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Intervention Group | Wait List Control Group |
|---|---|---|---|
| Fall from chair to knee | Musculoskeletal and connective tissue disorders | 1 of 15 | 0 of 18 |
The registry records zero serious adverse events among 15 participants at risk in the intervention group and zero among 18 participants at risk in the wait-list control group. It records one other adverse event among 15 at risk in the intervention group and zero among 18 at risk in the wait-list control group. Deaths are recorded as zero in both groups. No serious adverse-event terms are listed.
These figures are counts, not a full comparative safety analysis. The registry does not describe the other adverse event, its timing, severity, relationship to the intervention, or whether it led to a change in participation. It also does not report how adverse events were collected or how long participants were observed for safety. The figures should therefore be read as the adverse-event entries in the registry, not as proof that no additional events occurred.
Zero recorded serious events does not establish zero risk, particularly in a pilot study. Likewise, the difference in the recorded other-event counts cannot by itself show whether the intervention caused an event or whether the groups differed in underlying risk. The registry record does not report a formal safety comparison.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, unmasked pilot study evaluated a balance and strengthening program for older adults with heart failure, with the 30 Second Sit to Stand Test designated as the primary outcome. It describes supervised group exercise and home sessions for the intervention group, and a wait-list arrangement in which the control group initially continued usual activity. It also identifies the intended assessment at baseline and 12 weeks.
Those design details do not reveal what happened to the primary outcome. No group means, standard deviations, changes, treatment contrast, confidence interval, or p-value are reported. The direction, size, and precision of any difference are therefore unknown from the registry record. A reader cannot determine from this record whether scores improved, remained similar, or changed differently between groups.
The study’s stated goals also include balance, falls, perceptions, adherence, and feasibility. The registry record does not report numerical findings for those aims. The named secondary outcome, Activity Balance Confidence Scale, has no reported numerical result. The record’s adverse-event counts are limited and do not establish a causal safety profile.
This absence of results does not show that the intervention had no effect; it means the posted record does not provide the outcome estimates required to evaluate an effect. Nor does the study’s completion status indicate that a particular result was achieved. A statistical conclusion would require the outcome data, analysis methods, and appropriate handling of incomplete follow-up, none of which is reported for the primary outcome in the registry record.
The distinction is important: a trial’s question and design indicate what investigators intended to test, while results and their uncertainty indicate what the collected data support. Here, the registry record allows description of the intended comparison but does not permit a quantitative answer to the primary clinical question.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the difference between a registered study design and an interpretable outcome analysis. The registry identifies random allocation, a wait-list crossover structure, a continuous primary endpoint, and intended measurement times. Those details help a reader understand the question the study set out to address. They do not replace the numerical estimates needed to assess what the study found.
The primary measure is specified in a way that could support a quantitative comparison: a mean number of sit to stand cycles, with standard deviation, at baseline and 12 weeks. Yet no such estimates are reported in the registry record. Without them, the study cannot contribute a measurable effect or precision estimate to a reader’s understanding of the intervention based on this record.
The pilot context also matters statistically. Pilot studies can examine feasibility and inform later study planning, but their role does not eliminate the need to report outcome completion, variability, and uncertainty. The registry describes adherence and feasibility as aims but does not give their numerical findings. Any future planning based on an observed pilot effect would need to distinguish a planning assumption from a confirmed treatment effect.
Finally, the delayed-start design and the note about 12-week testing in the wait-list group make clear why analysis details and participant flow matter. In a design with multiple periods, readers need to know how observations were assigned to comparisons and how incomplete follow-up was handled. Those details are not reported. The record therefore illustrates why transparent reporting of estimates, uncertainty, analysis populations, and missing-data methods is essential for statistical interpretation.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main trial-specific limitation in interpreting the registry is the absence of numerical primary-outcome results. Although the record defines the 30 Second Sit to Stand Test, its units, summary measure, dispersion measure, and assessment times, it does not report scores or a comparative estimate. The primary treatment effect and its precision are consequently not assessable from this record.
The registry notes that two participants in the wait-list control group were there for testing at 12 weeks, but it does not provide a complete participant flow or clarify the status of other scheduled assessments. Reasons for incomplete outcome data and the method for handling missing observations are not reported. These gaps make it impossible to judge whether follow-up was complete or whether missingness could have affected an estimate.
The model is labeled crossover, and the wait-list group is described as receiving the intervention during weeks 12-24. The registry does not describe sequence details, a washout period, or an analysis of period and within-participant effects. No statistical analysis plan or interim-analysis information is reported in the registry record. The absence of listed analyses also means that there are no reported results to assess against the stated design.
Outcome reporting is incomplete for the broader aims as well. The record lists the Activity Balance Confidence Scale as a secondary outcome but does not report its findings; numerical results for the other stated aims are also not reported. Safety counts are available, but the non-serious event is not described and no formal safety analysis is reported. These are limitations of what can be concluded from the registry record, not evidence that an unreported outcome had a particular value.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Balance Training for Elders With Heart Failure — NCT02566785.
- Registry record last updated 2023-09-25; status last verified 2023-09.
- Results first posted 2018-10-09.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes NCT02566785, “Balance Training for Elders With Heart Failure,” also titled “Balance Activities and Strengthening to Improve Condition [BASIC]: Training for Elders With Heart Failure.” It lists the study as completed, randomized, unmasked, and crossover, with enrollment of 33. The sponsor is the University of Nebraska. The study started on 2016-02-01, and primary completion was 2016-12-16.
The intervention combined supervised group exercise and requested home exercise. The wait-list control group was asked to continue usual activity during the first 12 weeks and receive the intervention during weeks 12-24. The primary outcome was the baseline and 12-week 30 Second Sit to Stand Test, measured as the number of sit to stand cycles. Two participants in the wait-list control group were noted as being there for testing at 12 weeks.
The registry record does not report numerical primary-outcome results or analyses. It lists Activity Balance Confidence Scale as a secondary outcome and records no serious adverse events in either group. The outcome effect and its precision are not reported in the registry record.